An observational study in Shoulder Arthritis, Shoulder Osteoarthritis and Arthrosis, sponsored by Limacorporate S.p.a. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-04-06.
Sponsored by Limacorporate S.p.a (part of Enovis) · Observational
Help build ClinicalTrials.gg — short surveys, remote interviews or testing, in your language. Take part →
Among 13 studies in Osteoarthritis by Enovis — 2 open to participants now, 2 under way, none of them phase 3. Osteoarthritis · Enovis.
Among the 13 studies in Osteoarthritis by Enovis, this one is the only one that started in 2022, is one of 7 observational ones, and was the 13th registered.
2,974 studies on the registry are indexed under Osteoarthritis; 435 are open to participants now.
Browse Osteoarthritis studies →2 of the 13 studies in Osteoarthritis by Enovis are open now, in 1 country. Recruiting first, the newest first:
Limacorporate S.p.a · Sites in United States
Ages 22+
By country, each count listing its studies:
Of the 285 Osteoarthritis studies recruiting now, 157 (55%) set no upper age limit and 71 (25%) stop at 75 or younger; 22 take children under 18; 30 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
13 studies; the count open now beside each. This study's row is marked.
First in 2000; this study’s year is marked. 1 started in 2022.
This study's planned enrollment of 100 is close to the median of 100 across 601 observational studies indexed under Osteoarthritis.
Median enrollment 151 across the 6 interventional studies, 175 across the 7 observational. Of the 10 that completed or were terminated, 2 (20%) have results posted.
This tab as a report to print or save as PDF → With an account.
This study is registered under Limacorporate S.p.a, one of the names counted as Enovis. Under that name alone:
Limacorporate S.p.a is the lead sponsor of 31 studies on the registry; 12 are open to participants now.
1 of the studies in Osteoarthritis by Enovis that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05314387Limacorporate S.p.aS-11 SMR TT Hybrid Glenoid and Cementless Finned Short Stem | 2027-04 |
Add it to your calendar (.ics) → With an account.
Among the 13 studies in Osteoarthritis by Enovis, from their registry updates:
This tab as a report to print or save as PDF → With an account.
Post-market, prospective, non randomized, open label, multicentre, clinical study analysing outcomes of shoulder arthroplasty with SMR TT Hybrid Glenoid with or without SMR Cementless Finned Short Stem
Orthopedic Clinics
Inclusion Criteria:(Key)
A diagnosis in the target shoulder of one or more of the S-11 SMR TT Hybrid Glenoid and Cementless Finned Short Stem Version Sep 2021 2.0 Confidential Page11 following:
Exclusion Criteria (Key):
These are key eligibility criteria, other eligibility criteria apply.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients implanted with SMR TT Hybrid Glenoid without Cementless Finned Short Stem
Device: SMR TT Hybrid Glenoid without Cementless Finned Short Stem
Patients implanted with SMR TT Hybrid Glenoid with Cementless Finned Short Stem
Device: SMR TT Hybrid Glenoid with Cementless Finned Short Stem
The subject SMR Hybrid Glenoid System and SMR cementless finned short stem is intended for both primary or revision anatomic and reverse shoulder joint replacement. The glenoid components when used as part of an anatomic shoulder replacement are intended for cemented fixation.
The subject SMR Hybrid Glenoid System and SMR cementless finned short stem is intended for both primary or revision anatomic and reverse shoulder joint replacement. The glenoid components when used as part of an anatomic shoulder replacement are intended for cemented fixation. The fins are intended to enhance press-fit fixation. The same proximal morse taper is used for coupling to the same humeral bodies in the SMR Shoulder System. The SMR finned short stem is intended for cementless fixation.
Proportion of patients reaching a clinical progression from baseline to 24-month follow-up
The primary endpoint consists of the proportion of patients reaching a clinical progression from baseline to 24-month follow-up measured as: * Constant score improvement of greater than 10; * Adjusted Constant score greater than or equal to 54.
Time frame: 24 Months
Measure American Shoulder and Elbow Surgeons Shoulder Score (ASES)
The ASES questionnaire is composed of both a physician-rated component and a patient-reported component. The patient questions focus on joint pain, instability, and activities of daily living. Scores range from 0 to 100 with a score of 0 indicating a worse shoulder condition and 100 indicating a better shoulder condition.
Time frame: Baseline to 24 and 60 Months
Measure Oxford shoulder score
Oxford Shoulder Score (OSS) is a 12-item patient-reported PRO specifically designed and developed for assessing outcomes of shoulder surgery.
Time frame: Baseline to 24 and 60 Months
Measure Constant Score
The Constant-Murley score (CMS) is a 100-points scale composed of a number of individual parameters. These parameters define the level of pain and the ability to carry out the normal daily activities of the patient. The higher the score, the higher the quality of the function.
Time frame: Baseline to 24 and 60 Months
Measure Simple Shoulder Test
Simple Shoulder Test (SST) is a series of 12 "yes" or "no" questions the patient answers about the function of the involved shoulder. The answers to these questions provides a standardized way of recording the function of a shoulder before and after treatment. The difference between the shoulder function before treatment and after the recovery period is the effectiveness of the treatment.
Time frame: Baseline to 24 and 60 Months
Measure Patient Satisfaction
The satisfaction of the patients with regard to the effectiveness of the prosthetic treatment is graded on a scale from 1 to 5
Time frame: Baseline to 24 and 60 Months
Stability of the SMR TT hybrid glenoid component with or without SMR cementless finned short stem
Rate of symptomatic radiolucent lines, loosening and subsidence ≥2 mm
Time frame: Immediately postoperative to 24 Months
System conversion rate, intended as a conversion within the SMR system from anatomic to reverse
The SMR shoulder system is a modular system and in case of evolution of the pathology it may be easily converted from one configuration to another.
Time frame: 24 Months
Failure rate, intended as removal of the SMR TT hybrid glenoid component
A removal of the glenoid component is intended as a revision and a failure of the implant.
Time frame: Immediately postoperative to 24 Months
Failure rate, intended as removal of the SMR cementless finned short stem
A removal of the stem component is intended as a revision and a failure of the implant.
Time frame: Immediately postoperative to 24 Months
Incidence of device-related AE/SAE (ADE/SADE)
Device Related Adverse Events/Serious Adverse Events, device deficiencies, malfunctions and use errors at all follow-up time points
Time frame: Immediately postoperative to 24 and 60 Months
Survival rate (Kaplan-Meier)
Time frame: 60 Months
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Apr 2022; primary completion for Apr 2027, 60 months later.
Of 82 industry-sponsored observational studies under Osteoarthritis, half reached primary completion within 93 months of starting (the median), counting those still running; a quarter within 43 and three quarters within 184. This study's planned 60 months is below that.
Counting every sponsor, half of 228 studies reached it within 57 months; a quarter within 21 and three quarters within 141.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.